Enbrel
etanercept
etanercept
Keep this leaflet. You may need to read it again.
Your doctor will also give you a Patient Card, which contains important safety information that you need to be aware of before and during treatment with Enbrel.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or a child in your care. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or those of the child you are caring for.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Information in this leaflet is organised under the following 7 sections:
What Enbrel is and what it is used for
What you need to know before you use Enbrel
How to use Enbrel
Possible side effects
How to store Enbrel
Contents of the pack and other information
Instructions for preparing and giving an injection of Enbrel (See overleaf).
Enbrel is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Enbrel works by reducing the inflammation associated with certain diseases.
In adults (aged 18 and over), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis – in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities. For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Enbrel can slow down the structural damage to those joints caused by the disease.
Enbrel is also prescribed for the treatment of the following diseases in children and adolescents
For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years
Psoriatic arthritis in patients from the age of 12 years
For enthesitis-related arthritis in patients from the age of 12 years when other widely used treatments have not worked well enough or are not suitable for them
Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
if you or the child have, or are at risk of developing a serious blood infection called sepsis. If you are not sure, please contact your doctor.
if you or the child, have an infection of any kind. If you are not sure, please talk to your doctor.
Talk to your doctor before taking Enbrel.
immediately. Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.
Enbrel. Treatment with Enbrel may result in reactivation of hepatitis B in patients who have
previously been infected with the hepatitis B virus. If this occurs, you should stop using Enbrel.
Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer.
Some children and teenage patients who have received Enbrel or other medicines that work the same way as Enbrel have developed cancers, including unusual types, which sometimes resulted in death.
Some patients receiving Enbrel have developed skin cancers. Tell your doctor if you or the child
develop any change in the appearance of the skin or growths on the skin.
Your doctor will determine if preventive treatment for chickenpox is appropriate.
Please tell your doctor if you or the child in your care have a history of alcohol abuse.
Enbrel should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor. You or the child should not use Enbrel with medicines that contain the active substance anakinra or abatacept.
Enbrel should only be used during pregnancy if clearly needed. You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.
If you received Enbrel during pregnancy, your baby may have a higher risk of getting an infection. In addition, one study found more birth defects when the mother had received Enbrel in pregnancy, compared with mothers who had not received Enbrel or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported. Another study found no increased risk of birth defects when the mother had received Enbrel in pregnancy. Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby. It is important that you tell
the baby’s doctors and other healthcare professionals about the use of Enbrel during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Women using Enbrel should not breast-feed, since Enbrel passes into human breast milk.
The use of Enbrel is not expected to affect the ability to drive or use machines.
Always use this medicine exactly as the doctor has told you. Check with the doctor or pharmacist if you are not sure.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin. However, your doctor may determine an alternative frequency at which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg twice a week or 50 mg once a week.
Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response. If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease. The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of Enbrel per kg of bodyweight (up to a maximum of 50 mg) given once weekly.
For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly. If Enbrel has no effect on the child’s condition after 12 weeks, your doctor may tell you to stop using this medicine.
Enbrel is administered by an injection under the skin (by subcutaneous injection). Enbrel can be taken with or without food or drink.
The powder must be dissolved before use. Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”. Do not mix the Enbrel solution with any other medicine.
To help you remember, it may be helpful to write in a diary which day(s) of the week Enbrel should be used.
If you have used more Enbrel than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. Always have the outer carton of the medicine with you, even if it is empty.
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose. Then continue to inject the medicine on the usual day(s). If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose.
Your symptoms may return upon discontinuation.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, do not inject more Enbrel. Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Trouble swallowing or breathing
Swelling of the face, throat, hands, or feet
Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
If you notice any of the following, you or the child may need urgent medical attention.
Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints
Signs of blood disorders, such as bleeding, bruising, or paleness
Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg
Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips
weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin
Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision
Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue
Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal). If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
The known side effects of Enbrel include the following in groups of decreasing frequency:
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at an injection site that was recently used); and headache.
Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).
Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
The side effects and their frequencies seen in children and adolescents are similar to those described above.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2C – 8C). Do not freeze.
Before preparing the Enbrel solution, Enbrel may be stored outside of the refrigerator at temperatures up to a maximum of 25C for a single period of up to four weeks; after which, it should not be refrigerated again. Enbrel should be discarded if not used within four weeks after removal from the refrigerator. It is recommended that you record the date that Enbrel is removed from the refrigerator and the date after which Enbrel should be discarded (no more than 4 weeks following the removal from the refrigerator).
After preparing the Enbrel solution, immediate use is recommended. However, the solution may be used for up to 6 hours when stored at temperatures of up to 25C.
Do not use this medicine if you notice the solution is not clear or contains particles. The solution should be clear, colourless to pale yellow or pale brown, with no lumps or flakes or particles.
Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance in Enbrel is etanercept. Each vial of Enbrel 25 mg contains 25 mg of etanercept.
The other ingredients are:
Powder: Mannitol (E421), sucrose and trometamol
Enbrel 25 mg is supplied as a white powder for solution for injection (powder for injection). Each pack contains 4 single-dose vials and 8 alcohol swabs.
Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Manufacturer:
Pfizer Manufacturing Belgium NV Rijksweg 12,
2870 Puurs Belgium
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Tél/Tel: +32 (0)2 554 62 11
PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T: +357 22 817690
Pfizer, spol. s r.o.
Tel: +420-283-004-111
Pfizer Kft.
Tel: +36 1 488 3700
Pfizer ApS
Tlf: +45 44 201 100
Vivian Corporation Ltd.
Tel: +35621 344610
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000
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Tel: +31 (0)10 406 43 01
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This section is divided into the following sub-sections:
The following instructions explain how to prepare and inject Enbrel. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the techniques of self-injection or on giving an injection to a child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
This injection should not be mixed with any other medicine.
Wash your hands thoroughly.
Select a clean, well-lit, flat working surface.
Take the ENBREL vial out of the refrigerator and place it on a flat surface.
You will also need the following items:
A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections
2 alcohol swabs
Inspect the expiry dates on both the Enbrel vial label and the water for injections. They should not be used after the month and year shown.
Remove the plastic cap from the Enbrel vial. Do NOT remove the grey stopper or aluminium ring around the top of the vial.
Use a new alcohol swab to clean the grey stopper on the Enbrel vial. After cleaning, do not touch the stopper with your hands.
Check that a needle is on your syringe; if you are not sure how to attach a needle ask your doctor or nurse.
Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 1). Be careful not to bend or twist the cover during removal to avoid damage to the needle.
Check your syringe contains 1 ml of water for injections.
If you are not sure how to fill your syringe ask your doctor or nurse.
Make sure your syringe does not contain any air bubbles.
With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2). If the needle is
correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper. Look for the needle tip inside the stopper window (see Diagram 3). If the needle is not correctly lined up, you will feel constant resistance as it goes through the stopper and no “pop”. Do not insert the needle at an angle, this may cause the needle to bend and/or prevent proper addition of the solvent into the vial (see Diagram 4).
Diagram 2 Diagram 3 Diagram 4
Push the plunger in VERY SLOWLY until all the water for injections is in the vial. This will help reduce foaming (lots of bubbles) (see Diagram 5).
Diagram 5
Leave the syringe in place. Gently move the vial in circles a few times, to dissolve the powder (see Diagram 6). Do NOT shake the vial. Wait until all the powder dissolves (usually less than 10 minutes). The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles. Some white foam may remain in the vial this is normal. Do NOT use Enbrel if all the powder in the vial is not dissolved within 10 minutes. Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
With the needle still in the vial, hold the vial upside down at eye level. Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 7). As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid. For adult patients, withdraw the entire volume. For children, remove only the portion of liquid as directed by your child’s doctor.
Diagram 7
With the needle still inserted in the vial, check the syringe for air bubbles. Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8). Slowly press the plunger to push bubbles out of the syringe and into the vial. When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Diagram 8
Pull the needle completely out of the vial. Again, do not touch the needle or allow it to touch any surface.
(Note: After you have completed these steps, a small amount of liquid may remain in the vial. This is normal.)
The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9). If you are self injecting, you should not use the outer area of the upper arms.
Diagram 9
A different site should be used for each new injection. Each new injection should be given at least 3 cm from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. (It may be helpful to keep notes on the location of the previous injections.)
If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion. Do NOT touch this area again before giving the injection.
When the cleaned area of skin has dried, pinch and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 10). With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.
Diagram 10
When the needle is completely inserted into the skin, release the skin that you are holding. With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 11).
Diagram 11
When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle it was when it was inserted.
Press a cotton ball over the injection site for 10 seconds. Slight bleeding may occur. Do NOT
rub the injection site. A bandage is optional.
The syringe and needle should NEVER be re-used. Never recap a needle. Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.